Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate

Phase 1 Completed 10 enrolled Bayer

RandomizedCrossoverOpen-labelOther

Summary

This study is planned to explore the effect of food on the oral pharmacokinetics, the intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore, this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects.

Timeline

Start: 2017-08-18
Primary completion: 2018-01-22
Completion: 2018-07-20

Publications

Feldmuller M, Jodl SJ, Ploeger B, Wagenfeld A, Wiesinger H, Zollmann FS, Klein S, Zhang R, Rohde B, Hochel J. Zabedosertib, a novel interleukin-1 receptor-associated kinase-4 inhibitor, shows a favorable pharmacokinetic and safety profile across multiple phase 1 studies. Front Pharmacol. 2025 May 30;16:1521505. doi: 10.3389/fphar.2025.1521505. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BAY1834845	Unknown	—	Oral
Subject	Methotrexate	Small molecule	—	Oral

Indications

No indication recorded.